ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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30927 results sorted by trial registration date.
  • Burst Ketamine Infusions for Patients with Chronic Refractory Pain

    The aim of this study is to explore the long-term pain relieving effect after receiving ketamine infusions. There is a need to monitor the psychological, social and functional outcomes of patients receiving this treatment. We hypothesise that ketamine infusions will improve the pain experience for those with chronic refractory pain. Your pain specialist will determine if you are eligible to participate based on your symptoms. You will need to sign a consent form prior to any further information being collected. After this you will need to complete a baseline questionnaire asking about your history with ketamine infusions as well as some common pain, psychological and social measures. You will receive three burst ketamine infusions lasting 4 hours, 2-3 weeks apart. At the end of the infusion you will be asked to complete several questionnaires about your pain as well as some information regarding any side effects experienced. At two months and three months after your course of burst ketamine treatments you will need to complete a set of questionnaires again on pain and psychosocial measures. At each point the questionnaires will take you about 30 minutes and you have the option to complete the majority of them online via email in order to make the process more convenient.

  • MDS05/D2 - Phase Ib/II study for treatment of Myelodysplasia (MDS) with SRA515 and ASTX727,

    This is an open label, Phase Ib/II trial with a randomized platform design study for treatment of myelodysplasia. The purpose of this trial is to determine the safety and efficacy of treatment by adding SRA515 to ASTX727 in intermediate and high risk MDS. This multi-centre trial will recruit participants across Australia and New Zealand. Up to 26 subjects will be recruited for the dose-determining phase (Phase Ib) and at least a further 60 patients in the dose expansion phase. Who is it for? You may be eligible to join this study if you are aged 16 years or above and have a diagnosis of MDS or acute myeloid leukaemia (AML) with <30% blasts. Study Details This study will be conducted in two phases with cycles of 28 days. Phase Ib (Safety and Dose-Determination) will determine safety, tolerability and Recommended Phase II Dose (RP2D). Subjects will receive 35mg of ASTX727 by oral capsule on Days 1-5 of each cycle followed by a starting dose of 10mg of SRA515 by oral capsule on days 6-15. Phase II (Dose-Expansion) will assess preliminary signs of efficacy by monitoring overall response rates in participants for a minimum of 6 cycles. Patients will continue receiving therapy until experiencing an event as detailed in the MDS05 Master Protocol. During treatment participants will be assessed routinely for treatment-related toxicity events and investigators will modify treatment dosage or, if necessary, discontinue treatment. After treatment, disease will continue to be monitored and if participants have MDS progression or morphological relapse they will be assessed for the next best treatment option. It is hoped that the results of this trial will help determine if, and what dosage of, SRA515 in combination with ASTX727 is a safe and effective treatment option for patients with MDS or AML.

  • A Prospective study of the Safety and Effectiveness of Uterine Artery Embolization for the treatment of Endometriosis (UAE-E) – a Pilot Study

    Uterine Artery Embolisation (UAE) is accepted in Australia to treat uterine leiomyomas (fibroids). There is also growing literature to support UAE for the treatment of symptomatic adenomyosis (a condition when the tissue that lines the uterus grows into the muscular wall of the uterus). Adenomyosis and endometriosis are both disorders of the endometrial tissue that lines the uterus. UAE is a procedure where an embolic agent (a gel or glue) is placed in the uterine artery to limit the blood flow to areas of the uterus. It is a minimally invasive procedure performed by an Interventional Radiologist under image guidance. A small incision is made in the groin or the arm and a catheter (a long narrow tube) is placed in the artery and, under image guidance the catheter is directed to the artery to be treated. Once the catheter is in place the embolic agent is placed in the artery and the catheter is removed. UAE is not approved to treat endometriosis. Therefore, it is an experimental treatment for endometriosis. This means that it must be tested to see if it is an effective treatment for endometriosis. In this trial, the researcher would like validate that embolisation is a safe procedure and will provide improvement in the symptoms of endometriosis for patients with endometriosis.

  • A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia (PHN) Patients

    This study is a prospective, randomized, double-blind, placebo-controlled, Phase 1b clinical study to evaluate the safety, tolerability, PK, and PD of oral multiple-ascending doses (MAD) of iN1011-N17 after Oral Administration in Healthy Volunteers and OsteoarthritisPost-Herpetic Neuralgia Patients and to Assess the Relative Bioavailability of Mesylate vs Hydrochloride Salt Capsules in Healthy Volunteers. The study will be conducted with approximately in 3 parts. 56 healthy volunteers and 8 PHP patients will enrolled in up to 8 sequential MAD dose cohorts (Cohorts 1 to 8), each cohort can commence after the corresponding dose cohort has been completed and after Safety Review Committee (SRC) approval.

  • Safe Tibial Subsidence Pattern of a Medial Pivot Knee. A Radiostereometric Analysis (RSA) Study

    BACKGROUND Micromotion analysis supports effective cemented tibial component fixation in Total Knee Replacement (TKR) but a paucity of literature exists for medial pivot designs. This clinical study examined the tibial component micromotion and clinical scores in a second-generation medial pivot TKR. METHODS This prospective single-center clinical cohort trial involved 35 patients with a mean patient age of 71 years. Operations were performed by one experienced arthroplasty surgeon using the SAIPH implant (MatOrtho). All patients received fully cemented fixation with patella resurfacing. Other variables were standardized. Radiostereometric Analysis was performed at 6 weeks and 12 months to monitor tibial component behavior. The working hypothesis of this study is that the SAIPH tibial baseplate achieves stable fixation using bone cement in subjects undergoing TKR

  • Can we reduce pain and improve mobility after keyhole surgery for removal of the gallbladder by enhancing intraoperative care?

    Improving surgical and pain relief techniques in laparocopic cholecystectomy has been exhaustively studied. However, in contrast to that, strongly contradicting evidence exists. This study seeks to examine if changes in surgical technique may be able to lessen the impact of surgery on health, by minimising the surgical insult and therefore facilitating an earlier discharge from hospital.

  • Does delaying starting protein benefit late preterm and term surgical newborns?

    Parenteral nutrition (PN), consisting of carbohydrate, lipid, and amino acid constituent parts, is used in newborns when enteral feeding is insufficient. Those newborns requiring major surgery in the immediate postnatal period, comprising 17% of all late preterm and term newborns admitted to Australian NICUs per annum, are one such group with current supportive management emphasizing the importance of early nutrition. Recent data in children challenges this and suggests potential benefit from delayed provision of amino acids in the acute phase of a critical illness. The PEPaNIC (early vs late parenteral nutrition in the Paediatric ICU) RCT found that delaying PN (specifically amino acids) for a week following PICU admission reduced the length of admission by 30% and duration of ventilation by 40%, effects magnified on post-hoc analysis of the youngest patients. Confirmation of a similar response in ill surgical newborns is needed to drive practice change and improve both short- and longer-term clinical outcomes. Although the exact mechanism(s) remains unclear, the well newborn is exposed to a period of fasting for 48-72 hours following birth before the establishment of maternal milk supply, with fasting also a natural response to illness or surgical stress. Fasting results in up-regulation of autophagy which defines a phenotype of healing and repair, and which critically is suppressed by provision of amino acids. We hypothesize that delayed compared to early provision of the amino acid component of PN in late-preterm and term newborns requiring major surgery in the immediate neonatal period will shorten the duration of neonatal intensive care admission. The aim of this multi-centre, parallel group, superiority, blinded randomised controlled trial is to investigate the impact of delayed provision of the amino acid component of PN (intervention) versus early initiation (standard care) in late-preterm and term newborns requiring major surgery in the immediate newborn period on the duration of neonatal intensive care admission.

  • Does taking cannabidiol (CBD) oil with food affect the amount we absorb?

    Cannabidiol (CBD) is a safe non-psychoactive compound in cannabis. It is available with a prescription under the special access scheme. It is available without prescription when approved at dosages less than 150mg. CBD (100mg) in coconut oil (1ml) will be administered to healthy volunteers (n=16) to determine it is present in the blood over time at safe and effective levels. Taking CBD with a fatty meal has been shown to increase blood concentrations. It is not known if taking it with coconut oil will produce a similar effect. The volunteers will receive CBD in coconut oil when fasting and on the second visit after a high-fat breakfast. The CBD (and its metabolites) levels will be monitored via blood collection and LC-MS/MS analysis using a previously validated method. It is expected the CBD levels will approach that of the high-fat group when administered with coconut oil.

  • Study of Paediatric Appendicitis Scores and Management Strategies in Children Aged 5 to < 18 years presenting to Australian and New Zealand Emergency Departments

    Abdominal pain is a common reason for children to attend the Emergency Department (ED), with acute appendicitis is the most frequent cause of abdominal pain requiring surgical intervention with the highest incidence occurring in 10-to-20-year olds. Ruling in and ruling out the diagnosis of appendicitis is the main concern for acute care clinicians confronted with a child with abdominal pain with various clinical prediction scores (CPSs) developed to assist with diagnosing appendicitis. Most CPSs involve calculating a score based on combinations of different clinical features and laboratory findings to classify patients into low, intermediate, or high risk for appendicitis. The most frequently used scores in children are the Alvarado score, Pediatric Appendicitis Score, and the pediatric Appendicitis Risk Calculator. In addition, several other scores have been postulated in the literature with varying degrees of application and accuracy in children. However, CPSs have been inadequately validated and haphazardly adopted in Australia and New Zealand (ANZ), resulting in an increasing number of children undergoing unnecessary imaging and laboratory investigations compared to previous clinical practice. This project aims to address this issue by externally validating various commonly used CPSs in children aged 5 to <18 years presenting to ANZ EDs with acute abdominal pain with the suspicion of appendicitis and compare the CPSs’ performances against local clinician gestalt. This will improve accuracy of diagnosis, reduce healthcare costs, rationalise the use of healthcare resources, and improve management of childhood appendicitis. It will also provide a description of the current diagnostic and management approaches in ANZ for paediatric abdominal pain and appendicitis.

  • Evaluation of feasibility and effectiveness of the Mindgardens Functional Neurological Symptom Disorders (FND) Tic program for children and adolescents.

    There is a lack of coordinated service provision for children and adolescents in NSW and Australia with functional and Chronic Tic Disorders, hindering efforts to systematically collect clinical data that can be translated into gold-standard practice and shape service development. Clinical expertise in Tic Disorders, including Tic Disorders, remains limited to tertiary centres and primary and secondary care clinicians report feeling ill-equipped in caring for young patients. Current service models cater poorly to young people with Tic Disorders (including Tourette Syndrome) where collaborative input in assessment and management planning is essential. The proposed Mindgardens FND Tic program (for children and adolescents with Tic Disorders) is a tertiary assessment and intervention program for children and adolescents providing multi-disciplinary assessment and a brief intervention program for suitable patients. This program will see participants referred by their GP or specialist with a diagnosis of a Tic Disorder including functional Tic Disorder, Chronic Tic Disorder, or Tourette Syndrome. Two different streams will form part of this research study. Such a program is not currently available in Australia in the public sector and is a significant gap in care provision for a group with high rates of physical and mental health (MH) morbidity, disability and healthcare utilisation Significance, Innovation & Benefit Given the increasing morbidity rates among children and adolescents with a diagnosis of Tic Disorders and the potential perceived stigma and poor mental health literacy for accessing the healthcare system, children and adolescents attending this program will benefit from the specialised intervention leading to positive health outcomes. Additionally, this pilot work will also help inform health service practice, planning, and policy, and improve resource allocation and capacity building.

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